IRB Tips of the Month!

1. Please remember that information sheets and recruitment are required for most exempt studies in Section 40 in iStar. 

2. Adverse Events that are unexpected, related or possibly related, and are either serious or place subjects or others at a greater risk of harm than was previously known or recognized, must be reported to the IRB as soon as possible, but not later than 10 working days after the investigator becomes aware of the event.